![]() |
|
![]() |
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
Baylor College of Medicine |
Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00578292 |
The major goal of this study is to determine the amount of liver fibrosis and iron storage in a patient's liver before transplant (bone marrow/stem cell) from an unrelated donor. Too much liver damage could mean that there will be more problems with the transplant, and that medications that can further damage the liver need to be adjusted.
Condition | Intervention | Phase |
Thalassemia |
Drug: Busulfan Drug: Fludarabine Drug: Campath 1H Drug: Cyclophosphamide Drug: MESNA Procedure: Bone marrow or stem cell infusion |
Phase II |
Genetics Home Reference related topics: | beta thalassemia |
MedlinePlus related topics: | Thalassemia |
ChemIDplus related topics: | Mesna Cyclophosphamide Fludarabine Fludarabine monophosphate Alemtuzumab Campath Busulfan |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Pilot Study of Allogeneic Stem Cell Transplantation From Unrelated Donors for Patients With Severe Homozygous Beta 0/+ Thalassemia or Severe Variants of Beta 0/+ Thalassemia |
Estimated Enrollment: | 15 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Patients: Experimental
Patients with diagnosis of severe (transfusion-dependent) homozygous b0/+-thalassemia or severe variants of b0/+-thalassemia requiring chronic transfusion therapy and iron chelating agents.
|
Drug: Busulfan
4.0 mg/kg/day divided into four doses daily for four days; total dose = 16 mg/kg days -9 through -6
30mg/m2 day -5 through day -2
Drug: Campath 1H
per institutional guidelines days -5 through -2
Drug: Cyclophosphamide
50mg/kg days -5 through -2
Drug: MESNA
10mg/kg x 5 days -5 through -2
Procedure: Bone marrow or stem cell infusion
day +2 To ensure the probability for bone marrow engraftment, 4 x 108 nucleated cells/kg patient weight or 5 x 106/kg of CD34+cells/kg patient weight if the product is mobilized peripheral blood, will be the target to be obtained from the unrelated donor.
|
![]() |
Show Detailed Description |
Ages Eligible for Study: | up to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with documented diagnosis of severe (transfusion-dependent) homozygous b0/+-thalassemia or severe variants of b0/+-thalassemia requiring chronic transfusion therapy and iron chelating agents who fulfill the following conditions:
Exclusion Criteria:
Contact: Kathryn Suet Wa Leung, MD | 832-822-4200 | kleung@bcm.edu |
Contact: Kathryn Suet Wa Leung, MD | 832-822-4200 | kleung@bcm.tmc.edu |
United States, Texas | |||||
Texas Children's Hospital | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Contact: Marlen Dinu 832-824-4881 mxdinu@txccc.org | |||||
Contact: Kathryn Suet Wa Leung, MD 832-822-4200 kleung@bcm.tmc.edu | |||||
Principal Investigator: Kathryn Suet Wa Leung, MD |
Baylor College of Medicine |
Principal Investigator: | Kathryn Suet Wa Leung, MD | Baylor College of Medicine/Texas Children's Hospital |
Responsible Party: | Baylor College of Medicine/Texas Children's Hospital ( Kathryn Suet Wa Leung ) |
Study ID Numbers: | 14539, THALLO |
First Received: | December 19, 2007 |
Last Updated: | February 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00578292 |
Health Authority: | United States: Institutional Review Board |
|
|
|
|
|
|
![]() |